Biomarkers for the prediction of preterm birth

Abstract

The present disclosure provides biomarkers useful for determining the risk of, prognosis of, and/or diagnosis of conditions such as preterm birth in a subject.

What is claimed is: 
     
         1 .- 14 . (canceled) 
     
     
         15 . A method of diagnosing preterm birth comprising:
 quantifying the amount of Progesterone Receptor Membrane Component 1 (PGRMC1) present in a biological sample derived from a pregnant subject, wherein   the subject is indicated as having an increased risk for preterm birth if the amount of the PGRMC1 biomarker is altered in the biological sample derived from the subject compared to a reference control.   
     
     
         16 . The method of  claim 15 , wherein the biological sample is selected from the group consisting of tissues, cells, biopsies, blood, lymph, serum, plasma, urine, saliva, mucus, and tears. 
     
     
         17 . The method of  claim 16 , wherein the biological sample comprises plasma and the amount of the PGRMC1 biomarker is greater in the plasma derived from the subject compared to the reference control. 
     
     
         18 . The method of  claim 15 , wherein the PGRMC1 is a polypeptide and the quantifying is carried out by an assay comprising one or a combination of Western Blotting, Array system, affinity matrice, and immunoassay. 
     
     
         19 .- 25 . (canceled) 
     
     
         26 . The method of  claim 15 , wherein the biological sample is derived from the subject prior to 24 weeks of gestation. 
     
     
         27 . The method of  claim 15 , wherein the biological sample is derived from the subject at about 28 weeks of gestation. 
     
     
         28 . The method of  claim 15 , further comprising administering an appropriate prophylactic progesterone therapy if the subject is predicted as having an increased risk for preterm birth. 
     
     
         29 . A method for determining the efficacy of a preterm birth treatment comprising:
 determining a baseline value for the amount of Progesterone Receptor Membrane Component 1 (PGRMC1) present in a first biological sample comprising plasma derived from a pregnant subject; and   determining a post-treatment value for the amount of PGRMC1 present in a second biological sample comprising plasma derived from the pregnant subject after the subject has been administered a treatment for the preterm birth, wherein an observed decrease in the value for the amount of PGRMC1 present in the post-treatment sample compared to the baseline value is correlated with the efficacy of the therapeutic regimen.   
     
     
         30 . The method of  claim 29 , wherein the biological sample is selected from the group consisting of tissues, cells, biopsies, blood, lymph, serum, plasma, urine, saliva, mucus, vaginal secretions, cervical secretions, and tears. 
     
     
         31 . The method of  claim 29 , wherein the biological sample comprises plasma. 
     
     
         32 . The method of  claim 29 , wherein the PGRMC1 is a polypeptide and the quantifying is carried out by an assay comprising one or a combination of Western Blotting, Array system, affinity matrice, and immunoassay. 
     
     
         33 .- 53 . (canceled) 
     
     
         54 . A kit for diagnosing preterm birth comprising:
 i) a probe comprising an antibody or a binding fragment specific for PGRMC1 polypeptide for determining a level of PGRMC1 biomarker for preterm birth in a plasma sample derived from a pregnant subject;   ii) instructions for carrying out the determination of the biomarker level in the biological sample and for diagnosing the subject as having preterm birth if the level of the PGRMC1 biomarker is greater in the biological sample derived from the subject compared to a reference control; and   iii) reagents for determining the level of the PGRMC1 biomarker in the plasma sample.   
     
     
         55 . (canceled) 
     
     
         56 . The kit of  claim 54 , wherein the determination of the PGRMC1 biomarker level is carried out by an assay comprising one or a combination of Western Blotting, affinity matrice, and immunoassay. 
     
     
         57 . The kit of  claim 56 , wherein the immunoassay comprises one or a combination of immunocytochemistry, immunohistochemistry, competitive binding assay, a non-competitive binding assay, a sandwich assay, a fluoroimmunoassay, an immunofluorometric assay, an immunoradiometric assay, a luminescence assay, and a chemiluniescence assay. 
     
     
         58 . (canceled) 
     
     
         59 . (canceled) 
     
     
         60 . The kit of  claim 54 , wherein the probe is attached to a solid support. 
     
     
         61 .- 65 . (canceled) 
     
     
         66 . The kit of  claim 54 , wherein the biological sample is derived from the subject prior to 24 weeks of gestation. 
     
     
         67 . The kit of  claim 54 , wherein the biological sample is derived from the subject at about 28 weeks of gestation. 
     
     
         68 - 97 . (canceled)